Atlas FDA

CHEMKIT CARBAMAZEPINE DIAGNOSTIC KIT

FDA 510(k) clearance K834052 · decided 1984-01-24

Clearance details

K-number
K834052
Device name
CHEMKIT CARBAMAZEPINE DIAGNOSTIC KIT
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1983-11-23
Decision date
1984-01-24
Days to decision
62 days
Clearance type
Traditional
Product code
KLT
Device class
2
Regulation number
862.3645
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Abbott Park, IL, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

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Carbamazepine Gen 4 (K151578)Roche Diagnostics Operations (Rdo)2015-10-22
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ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS (K103627)Abbott Laboratories2011-10-14
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ONLINE TDM CARBAMAZEPINE (K031902)Roche Diagnostics Corp.2003-09-17
RANDOX CARBAMAZEPINE (K011648)Randox Laboratories, Ltd.2002-01-15
EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229 (K010814)Syva Co., Dade Behring, Inc.2001-04-13
ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM (K000903)Bayer Corp.2000-05-18
IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6 (K000007)Diagnostic Products Corp.2000-02-28
SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL (K993987)Syva Co.2000-01-27
ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1E12 AND 6E90 (K993028)Syva Co.2000-01-27

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046)Abbott Laboratories2025-04-03
ARCHITECT AFP / Alinity i AFP (P120008/S030)Abbott Laboratories2025-04-03
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043)Abbott Laboratories2025-04-03
ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066)Abbott Laboratories2025-04-03
ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012)Abbott Laboratories2024-09-30